UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II trial of 5-FU, cisplatin, and weekly paclitaxel in patients with esophageal cancer
Title of the study (Brief title)	Phase I/II trial of 5-FU, cisplatin, and weekly paclitaxel in patients with esophageal cancer
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	A phase I/II study of a combination of triweekly FP(5-fluorouracil plus cisplatin) and weekly paclitaxel(PCF) is carried out to determine the maximum tolerated dose (MTD), recommended dose (RD), dose-limiting toxicities (DLTs) and objective response rate (RR) in patients with advanced or recurrent esophageal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase I The maximum tolerated dose,recommended dose, and dose-limiting toxicities of weekly paclitaxel administration Phase II Response Rate of triweekly FP(5-fluorouracil plus cisplatin) and weekly paclitaxel (PCF).
Key secondary outcomes	Phase I Adverse events, and response rate of PCF Phase II Curative setting group(potentially resectable) Adverse events, pathological CR rate, progression free survival, and overall survival of PCF Palliative setting group(potentially unresectable) Adverse events, progression free survival, and overall survival of PCF

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	We add weekly paclitacel administration to triweekly 5-Fulorouracl 800mg/m2+ CDDP 80mg/m2. The starting dose of paclitaxel is 40mg/m2. If torelable, we increase doses of paclitaxel from 40mg/m2 to 60mg/m2. Next if tolerable, increase from 60mg/m2 to 80mg/m2.(the maximum dose)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1)A histologically confirmed diagnosis of gastric, gastroesophageal, or esophageal carcinoma. 2) Clinical stage IB, II, III, and IV(UICC-TNM) 3) Age 18 to 75 years 4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 5) Previous chemotherapy is allowed, but limited only one resimen contained of platinum and the last chemotheapy was carried out in more than six months ago. 6) Sufficient organ function 7) Peripheral neuropathy less than CTCAE-Grade 1 8) Patients who provided written informed consent by themselves in principle to participate in this trial.
Key exclusion criteria	Poor control DM, active other cancer, the past history of hyper sensitivity of study drugs, active infection, continuous use of steroid, peripheral neuropathy greater than CTCAE-Grade 2, active interstitial pneumonia, pulmonary fibrosis, psychiatric disorder, cardiopulmonary disorder(past history of angina in less than 4 weeks, myocardial infarction in less than 6 monthes, poor control congenitive heart failure), untolerable alcohol
Target sample size	47

Research contact person
Name of lead principal investigator	Masanori Watanabe
Organization	Nippon Medical School Musashi Kosugi Hospital
Division name	Department of Gastrointestinal Surgery
Address	1-396 Kosugi-chou, Nakahara-ku, Kawasaki city, Kanagawa, Japan
TEL	044-733-5181
Email	margaux@nms.ac.jp

Public contact
Name of contact person	Satoshi Nomura
Organization	Nippon Medical School Musashi Kosugi Hospital
Division name	Department of Gastrointestinal Surgery
Address	1-396, Kosugi-tyou, Nakahara-ku, Kawasaki city, Kanagawa, Japan
TEL	044-733-5181
Homepage URL
Email	isonosan@nms.ac.jp

Sponsor
Institute	Nippon Medical School Musashi Kosugi Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	日本医科大学武蔵小杉病院

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 01 Day
Anticipated trial start date	2014 Year 01 Month 01 Day
Last follow-up date	2019 Year 02 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 04 Month 04 Day
Last modified on	2019 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015898